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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Pharma / Biotech |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Position Title- Specialist - Clinical Safety Operations Job Location - Electronic city Bangalore Your Role: The Clinical Safety Operations Associate is a team member of the Clinical Safety Operations team. He/she provides leadership, management, general oversight, and direction for operational patient safety aspects in clinical trials, early access programs, investigator-sponsored studies, and related activities across the whole product portfolio of Healthcare.He/she is responsible for the oversight of patient safety operations, including maintenance of study-specific Safety Management Plan (SMP), Standard Operating Procedures (SOPs), Vendor oversight, Safety Monitoring Committee oversight, Informed Consent Form (ICF): Review and Safety Input, Query Management to sites, SAE Reconciliation (also for Investigator Sponsored Studies, ISS), Protocol Review, Agreement Review, Request for Proposals, and Vendor Selection, and further similar activities. We have ambitious goals and need ambitious people to reach them. If you re talented, hard-working, and make a habit out of dreaming big, we d like to hear from you.Who you are:
Keyskills :
standard operating proceduresdrug safetylife sciencespatient safetyproblem solvingclinical trialsprotocol reviewvendor selection